Wednesday, 12 September 2012

Kids Choice





Dosage Form: gel, dentifrice

ACTIVE INGREDIENT


Active Ingredient: Stannous Fluoride



INACTIVE INGREDIENTS


Glycerine, Hydroxy Ethyl Celluulose, Xylitol



USE


Aids in the prevention of dental decay.



KEEP OUT OF REACH OF CHILDREN


KEEP OUT OF REACH OF CHILDREN



DIRECTIONS FOR USE


Adults and Children 12 years and Older: Use after regular brushing and flossing.  Place gel across length of toothbrush.  Brush Thoroughly.  Keep on teeth for 1 - 1 1/2 minutes and then expectorate (spit out).  Do not swallow.  Use once a day for cavity prevention.  Supervise children until capable of using without supervision.


Children 6-11 Years:  See directions above.  Adult supervision required.


Children Under 6: Consult a Dentist or Physician.



OTHER INFORMATION


This is a fluoride prevention treatment gel, not a toothpaste.  Read directions carefully before use.  This product may produce surface discoloration of the teeth.  Adequate toothbrushing may prevent discoloration.  Discoloration is not harmful or permanent and may be removed by a dental professional.  Do not freeze or expose to extreme heat.



QUESTIONS ? COMMENTS ?


Questions?? Comments??


Call 1-479-787-5168 M-F 9am to 5pm CST



Warnings


If more than amount used for brushing is accidentally swallowed, seek medical help from a poison control center.



PACKAGE LABEL


Brush on Therapy for Cavity Prevention - Doctor's Choice 0.4% Stannous Fluoride Gel


Manufactured by Massco Dental




















Kids Choice 
stannous fluoride  gel, dentifrice










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)63783-005
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION)STANNOUS FLUORIDE.45103 g  in 120 g










Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
XYLITOL 


















Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUM (BUBBLE GUM)Imprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
163783-005-04120 g In 1 BOTTLE, DISPENSINGNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989







Kids Choice 
stannous fluoride  gel, dentifrice










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)63783-006
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION)STANNOUS FLUORIDE.4510 g  in 120 g










Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
XYLITOL 


















Product Characteristics
Color    Score    
ShapeSize
FlavorCREME DE MENTHE (HINT OF MINT)Imprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
163783-006-04120 g In 1 BOTTLE, DISPENSINGNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989







Kids Choice 
stannous fluoride  gel, dentifrice










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)63783-007
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION)STANNOUS FLUORIDE.4510 g  in 120 g










Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
XYLITOL 


















Product Characteristics
Color    Score    
ShapeSize
FlavorLIME (LIMEAIDE)Imprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
163783-007-04120 g In 1 BOTTLE, DISPENSINGNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989







Kids Choice 
stannous fluoride  gel, dentifrice










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)63783-008
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION)STANNOUS FLUORIDE.4510 g  in 120 g










Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
XYLITOL 


















Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (GRAPE)Imprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
163783-008-04120 g In 1 BOTTLE, DISPENSINGNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989







Kids Choice 
stannous fluoride  gel, dentifrice










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)63783-009
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION)STANNOUS FLUORIDE.4510 g  in 120 g










Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
XYLITOL 


















Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (CHERRY)Imprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
163783-009-04120 g In 1 BOTTLE, DISPENSINGNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989







Kids Choice 
stannous fluoride  gel, dentifrice










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)63783-015
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION)STANNOUS FLUORIDE.4510 g  in 120 g










Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
XYLITOL 


















Product Characteristics
Color    Score    
ShapeSize
FlavorCOTTON CANDY (COTTON CANDY)Imprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
163783-015-04120 g In 1 BOTTLE, DISPENSINGNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989


Labeler - Massco Dental A Division of Dunacin Pharmaceuticals (008081858)

Registrant - Massco Dental A Division of Dunacin Pharmaceuticals (008081858)









Establishment
NameAddressID/FEIOperations
Massco Dental A Division of Dunacin Pharmaceuticals008081858manufacture
Revised: 10/2011Massco Dental A Division of Dunacin Pharmaceuticals




More Kids Choice resources


  • Kids Choice Use in Pregnancy & Breastfeeding
  • Kids Choice Support Group
  • 3 Reviews for Kids Choice - Add your own review/rating


Compare Kids Choice with other medications


  • Prevention of Dental Caries

Aler-Tab


Generic Name: diphenhydramine (DYE fen HYE dra meen)

Brand Names: Aler-Tab, Allergy, Allermax, Altaryl, Benadryl Allergy, Benadryl DF, Benadryl Dye Free Allergy, Benadryl Ultratab, Children's Allergy, Diphen Cough, Diphenhist, Dytuss, PediaCare Children's Allergy, Q-Dryl, Q-Dryl A/F, Siladryl, Siladryl Allergy, Silphen Cough, Simply Sleep, Sleep-ettes, Sleep-ettes D, Sominex Maximum Strength Caplet, Theraflu Thin Strips Multi Symptom, Triaminic Thin Strips Cough & Runny Nose, Unisom Sleepgels Maximum Strength, Valu-Dryl


What is Aler-Tab (diphenhydramine)?

Diphenhydramine is an antihistamine. Diphenhydramine blocks the effects of the naturally occurring chemical histamine in the body.


Diphenhydramine is used to treat sneezing; runny nose; itching, watery eyes; hives; rashes; itching; and other symptoms of allergies and the common cold.


Diphenhydramine is also used to suppress coughs, to treat motion sickness, to induce sleep, and to treat mild forms of Parkinson's disease.


Diphenhydramine may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Aler-Tab (diphenhydramine)?


Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine.

What should I discuss with my healthcare provider before taking Aler-Tab (diphenhydramine)?


Do not take diphenhydramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have



  • glaucoma or increased pressure in the eye;




  • a stomach ulcer;




  • an enlarged prostate, bladder problems or difficulty urinating;




  • an overactive thyroid (hyperthyroidism);




  • hypertension or any type of heart problems; or




  • asthma.



You may not be able to take diphenhydramine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.


Diphenhydramine is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take diphenhydramine without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of antihistamines, and side effects could occur in a breast-feeding baby. Do not take diphenhydramine without first talking to your doctor if you are nursing a baby. If you are over 60 years of age, you may be more likely to experience side effects from diphenhydramine. You may require a lower dose of this medication.

How should I take Aler-Tab (diphenhydramine)?


Take diphenhydramine exactly as directed on the package or as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.


Take each dose with a full glass of water.

Diphenhydramine can be taken with or without food.


For motion sickness, a dose is usually taken 30 minutes before motion, then with meals and at bedtime for the duration of exposure.


As a sleep aid, diphenhydramine should be taken approximately 30 minutes before bedtime.


To ensure that you get a correct dose, measure the liquid forms of diphenhydramine with a special dose-measuring spoon or cup, not with a regular tablespoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.


Never take more of this medication than is prescribed for you. The maximum amount of diphenhydramine that you should take in any 24-hour period is 300 mg.


Store diphenhydramine at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.


What happens if I overdose?


Seek emergency medical attention if an overdose is suspected.

Symptoms of a diphenhydramine overdose include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.


What should I avoid while taking Aler-Tab (diphenhydramine)?


Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine.

Aler-Tab (diphenhydramine) side effects


Stop taking diphenhydramine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take diphenhydramine and talk to your doctor if you experience



  • sleepiness, fatigue, or dizziness;




  • headache;




  • dry mouth; or




  • difficulty urinating or an enlarged prostate.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Aler-Tab (diphenhydramine)?


Do not take diphenhydramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Talk to your pharmacist before taking other over-the-counter cough, cold, allergy, or insomnia medications. These products may contain medicines similar to diphenhydramine, which could lead to an antihistamine overdose.


Before taking this medication, tell your doctor if you are taking any of the following medicines:



  • anxiety or sleep medicines such as alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), temazepam (Restoril), or triazolam (Halcion);




  • medications for depression such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), fluoxetine (Prozac), sertraline (Zoloft), or paroxetine (Paxil); or




  • any other medications that make you feel drowsy, sleepy, or relaxed.



Drugs other than those listed here may also interact with diphenhydramine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.



More Aler-Tab resources


  • Aler-Tab Side Effects (in more detail)
  • Aler-Tab Use in Pregnancy & Breastfeeding
  • Aler-Tab Drug Interactions
  • Aler-Tab Support Group
  • 0 Reviews for Aler-Tab - Add your own review/rating


  • Banophen MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ben-Tann Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • Benadryl Consumer Overview

  • Benadryl Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • Benadryl Allergy Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Children's Allergy Prescribing Information (FDA)

  • Diphen Advanced Consumer (Micromedex) - Includes Dosage Information

  • Diphenhydramine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Diphenhydramine Prescribing Information (FDA)

  • Diphenhydramine Hydrochloride Monograph (AHFS DI)

  • Diphenoxylate Hydrochloride Monograph (AHFS DI)

  • Dytuss Elixir MedFacts Consumer Leaflet (Wolters Kluwer)

  • Simply Sleep MedFacts Consumer Leaflet (Wolters Kluwer)

  • Sominex MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Aler-Tab with other medications


  • Allergic Reactions
  • Cold Symptoms
  • Cough
  • Extrapyramidal Reaction
  • Hay Fever
  • Insomnia
  • Motion Sickness
  • Nausea/Vomiting
  • Pruritus
  • Urticaria


Where can I get more information?


  • Your pharmacist can provide more information about diphenhydramine.

See also: Aler-Tab side effects (in more detail)


Tuesday, 11 September 2012

Axorid modified-release capsules






Axorid 100 mg/20 mg,
Axorid 150 mg/20 mg,
Axorid 200 mg/20 mg,
modified-release capsules


Ketoprofen / Omeprazole




Read all of this leaflet carefully before you start taking this medicine.



  • Keep this leaflet. You may need to read it again.


  • If you have any further questions, ask your doctor or pharmacist.


  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


  • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.



In this leaflet:


  • 1. What Axorid is and what it is used for

  • 2. Before you take Axorid

  • 3. How to take Axorid

  • 4. Possible side effects

  • 5. How to store Axorid

  • 6. Further Information




What Axorid Is And What It Is Used For


Your medicine contains two active ingredients called ketoprofen and omeprazole.


Ketoprofen is a non-steroidal anti-inflammatory agent (NSAID) which reduces inflammation. Omeprazole is a « proton pump inhibitor » which reduces the amount of acid produced in your stomach.


Axorid is used in adults and adolescents over the age of 15 years for treating the symptoms of rheumatoid arthritis, a condition called “ankylosing spondylitis” and osteoarthritis.


You will be given this medicine if you need to be treated with an anti-inflammatory medicine and:


  • you have a history of stomach or duodenal ulcers,

  • you are at risk of developing these types of ulcers



BEFORE YOU TAKE Axorid



Do not take Axorid


  • if you are allergic to ketoprofen or to omeprazole

  • if you are allergic to any of the other ingredients in this medicine (these are listed in section 6, Further Information),

  • if you are in the last trimester (from the 7th month) of pregnancy,

  • if you have a history of asthma caused by ketoprofen or similar substances, such as aspirin or other non-steroidal anti-inflammatory medicines (NSAIDs),

  • if you have severe liver, kidney or heart disease,

  • if you have an active peptic ulcer,

  • if you have bleeding in your stomach, intestine (gut) or brain,

  • if you are under 15 years old.



Take special care with Axorid


Tell your doctor before taking this medicine if you:


  • have asthma or a history of asthma – this medicine may cause an asthma attack

  • have previously had a severe skin reaction caused by sunlight ,

  • have a history of Crohn’s disease or “ulcerative colitis” (Your doctor will have told you),

  • have liver, kidney or heart disease,

  • are pregnant or are trying to get pregnant.

Medicines such as ketoprofen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.


If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.


If you are taking this medicine for a long period of time, your doctor may need to do blood tests e.g. kidney and liver function tests, and blood counts.


Your doctor may also check your hearing and eyesight.


If you have any sign of bleeding in the stomach or intestine (gut), stop taking the capsules and tell your doctor immediately.




Taking other medicines


Do not take Axorid if you are taking the following medicines:


  • atazanavir (anti-HIV medicine)

  • a herbal remedy called St John’s wort

  • an antibiotic called clarithromycin if you have liver problems

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.


Tell your doctor before taking Axorid if you are being treated with any of the following:


  • aspirin or other non steroidal anti inflammatory agents (for treating pain and inflammation),

  • medicines used to reduce clotting of the blood (called thrombolytics, anticoagulants and anti-platelet agents),

  • corticosteroid anti-inflammatory medicines (to reduce inflammation),

  • phenytoin (used to treat epilepsy),

  • methotrexate (used to treat cancer),

  • lithium or medicines called “selective serotonin reuptake inhibitors” (SSRIs), which are used to treat some psychiatric disorders,

  • medicines to treat high blood pressure (called diuretics, ACE inhibitors and beta-blockers)

  • zidovudine (used to treat HIV infection),

  • ciclosporine and tacrolimus (used after an organ transplant to prevent rejection),

  • an intrauterine contraceptive device (“coil”),

  • medicines to treat depression and/or sleeping disorders (e.g. diazepam, triazolam, flurazepam, antidepressants and barbiturates),

  • disulfiram (used to treat chronic alcoholism),

  • digoxin (used to treat heart disorders),

  • ketoconazole and itraconazole (used to treat fungal infections),

  • vitamin B12 (taken by mouth) for treating vitamin B12 deficiency.



Taking Axorid with food and drink


The capsules should always be swallowed whole with a glass of water. They should also be taken with food e.g. at meal times




Pregnancy


Your doctor may prescribe this medicine for you during the first 6 months of your pregnancy, when strictly necessary.



From the 7th month of pregnancy, you must not under any circumstances take this medicine on your own initiative, as it may have serious consequences for your child’s health, particularly for the child’s heart, lungs and kidneys, even after only one dose.


Nevertheless, your gynaecologist might prescribe this medicine for you in certain very special cases. If this happens, you should follow strictly your doctor’s prescription.


Ask your doctor or pharmacist for advice before taking any medicine.




Breast-feeding


This medicine passes into breast milk. You should therefore avoid taking the capsules if you are breast-feeding a baby.




Fertility


Ketoprofen may impair fertility and is not recommended in women attempting to conceive.


Ask your doctor or pharmacist for advice before taking any medicine.




Driving and using machines


This medicine may cause sleepiness/ drowsiness, dizziness and visual disturbances.


If you are affected, you should not drive or operate machinery.




Important information about some of the ingredients of Axorid


This medicine contains, sucrose, propyl-p-hydroxybenzoate (E216) and methyl-p-hydroxy benzoate (E218) (parahydroxybenzoates)


  • If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine,

  • Parahydroxybenzoates may cause allergic reactions (possibly delayed).




How To Take Axorid


Always take Axorid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.


The capsules should not be chewed or crushed; they should always be swallowed whole with a glass of water. The capsules should also be taken with food e.g. at meal times.


Your doctor may prescribe:


  • One 100 mg/20 mg capsule daily

  • One 150 mg/20 mg capsule daily

  • One 200 mg/20 mg capsule daily

The dose depends on the severity of your symptoms. The maximum daily dose is one 200 mg/20 mg capsule.


An initial dose of one 100 mg/20 mg capsule is recommended in elderly patients, and in patients with liver, kidney or heart disorders. The dose may be increased by your doctor up to one 200 mg/20 mg capsule if necessary.



If you take more Axorid than you should


Contact your doctor or pharmacist immediately.




If you forget to take Axorid


Take it as soon as you remember. However, if it is almost time for your next dose, do not take a double dose to make up for forgotten individual doses, just take the next dose on time.





Possible Side Effects


Like all medicines, Axorid can cause side effects, although not everybody gets them.



If you experience any of the following side effects, tell your doctor immediately or go to your nearest hospital casualty department.



  • Serious allergic reaction which causes difficulty in breathing or dizziness, or swelling of the face or throat


  • Blistering of the skin, mouth, eyes and genitals


  • Red patches on the back of your hands and arms


  • Inflammation of the blood vessels, often with a rash


  • An asthma attack (breathing difficulties)


  • Fever, severe chills, sore throat, mouth ulcers, bleeding or bruising easily (you may have a blood disorder)


  • Blood in your stools


The following side effects have also been reported. If any of these get troublesome or serious, talk to your doctor.



Common side effects


(probably affecting less than 1 in 10 people):


  • Sleepiness/ drowsiness

  • Trouble sleeping

  • Spinning sensation

  • Headache

  • Gastrointestinal effects included: nausea, vomiting, diarrhoea, constipation, flatulence (wind), abdominal pain, gastrointestinal discomfort and pain


Uncommon side effects


(probably affecting less than 1 in 100 people):


  • Visual disturbances (e.g. blurred vision, problems focusing)

  • Ringing in the ears (tinnitus) and deafness

  • Changes in levels of liver enzymes in your blood

  • Taste disorders

  • Itching and skin rashes

  • Unusual hair loss

  • Skin sensitivity to light

  • Increased sweating

  • Swelling of the ankles, feet or hands

  • Mood disorders


Rare side effects


(probably affecting less than 1 in 1,000 people)


  • Changes in red blood cells

  • Pins and needles

  • Light headedness

  • Mental confusion and hearing sounds or seeing things that are not real

  • Brownish-black discoloration of the tongue whilst also taking clarithromycin (an antibiotic)

  • Muscle weakness

  • Muscle pain, joint pain

  • Heart failure

  • High blood pressure

  • Gastrointestinal ulcer

  • Gastrointestinal bleeding

  • Kidney or liver problems

  • Worsening of chronic urticaria (hives).


Very rare side effects


(probably affecting less than 1 in 10,000 patients)


  • Nettle rash (hives)

  • Fever

  • Agitation and depression

  • Dry mouth or inflammation of the mouth

  • Thrush

  • Inflammation of the pancreas which causes severe pain in the abdomen and back

  • Low blood sodium

  • Development of breasts in men

Medicines including Ketoprofen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.


Although not known with oral omeprazole, blindness and deafness have been reported with the injectable form.



If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




HOW TO STORE Axorid


Keep out of the reach and sight of children.


Do not store above 25°C. Store in the original container in order to protect from moisture.


Do not take your capsules after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further Information


What Axorid contains


  • The active substances are ketoprofen and omeprazole.


    Each 100mg/20mg modified release capsule contains 100 mg of ketoprofen and 20mg of omeprazole.


    Each 150mg/20mg modified release capsule contains 150 mg of ketoprofen and 20mg of omeprazole.


    Each 200mg/20mg modified release capsule contains 200 mg of ketoprofen and 20mg of omeprazole.

  • The other ingredients are:
    Capsule contents:


    sucrose, maize starch, hypromellose, dimethicone emulsion (containing propyl-p-hydroxybenzoate (E216), methyl-p-hydroxybenzoate (E218), sorbic acid, sodium benzoate, polysorbate 20, octylphenoxy polyethoxy ethanol and propylene glycol), polysorbate 80, mannitol, diacetylated monoglycerides, talc, Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, polyacrylate dispersion 30%, ammonio methacrylate copolymer type A, ammonio methacrylate copolymer type B, triethyl citrate, stearoyl macrogolglycerides, colloidal anhydrous silica,
    Capsule shell:
    • Axorid 100mg/20mg: yellow iron oxide (E 172), titanium dioxide (E 171), gelatin,
    • Axorid 150mg/20mg: black iron oxide (E 172), titanium dioxide (E 171), gelatin,
    • Axorid 200mg/20mg: titanium dioxide (E 171), gelatin.


What Axorid looks like and content of the packs


Axorid comes in three strengths containing 100 mg/20 mg, 150 mg/20 mg and 200 mg/20 mg of Ketoprofen/Omeprazole. Each strength of capsule is a different colour:


  • 100 mg/20 mg capsules have yellow caps and white bodies;

  • 150 mg/20 mg capsules have grey caps and white bodies;

  • 200 mg/20 mg capsules have white caps and bodies.

Axorid comes in a bottle containing 28 and 30 capsules.




Marketing Authorization Holder



Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop‘s Stortford

CM22 6PU




Manufacturers:



Ethypharm

17/21, rue Saint-Matthieu

F-78550 Houdan

France

Tel:+33 (0) 1 30 80 17 20

Fax:+33 (0) 1 30 88 17 30



Ethypharm

Chemin de la Poudrière

F-76120 Grand-Quevilly

France

Tel:+33 (0) 2 35 18 24 64

Fax:+33 (0) 2 35 18 24 61



Ethypharm

Z.I. de Saint Arnoult

F-28170 Châteauneuf en Thymerais

France

Tel:+33 (0) 2 37 65 88 00

Fax:+33 (0) 2 37 51 02 88



Pierre Fabre Médicament Production

Le Payrat

46000 Cahors

France

Tel:+33-5 65 23 57 00

Fax:+33-5 65 22 67 87



Rottendorf Pharma S.A.R.L

Z.I. No. 2 Batterie 1000

F-59309 Valenciennes

France

Tel:+ 33 / (0) 3 27 43 45 00

Fax:+ 33 / (0) 3 27 43 43 57



Rottendorf Pharma GmbH

Ostenfelder Str. 51-61

D-59320 Ennigerloh

Germany

Tel:+ 49 (0) 25 24 / 2 68 - 0

Fax:+ 49 (0) 25 24 / 2 68 – 100



Meda Pharma GmbH & Co. KG

Benzstrasse 1

D-61352 Bad Homburg

Germany

Tel:+ 49 (0) 6172 888 – 01

Fax:+ 49 (0) 6172 888 – 2740




This medicine is authorised in the member states of the EEA under the following names


UK:


Axorid 100 mg/20 mg, modified-release capsules


Axorid 150 mg/20 mg, modified-release capsules


Axorid 200 mg/20 mg, modified-release capsules


IT:


Axorid 100 mg/20 mg, modified-release capsules


Axorid 150 mg/20 mg, modified-release capsules


Axorid 200 mg/20 mg, modified-release capsules


ES, PL, PT and RO:


Keithon 100 mg/20 mg, modified-release capsules


Keithon 150 mg/20 mg, modified-release capsules


Keithon 200 mg/20 mg, modified-release capsules




This leaflet was last approved in December 2009






Gyne Cure Topical


Generic Name: tioconazole (Topical route)

tye-oh-KON-a-zole

Commonly used brand name(s)

In Canada


  • Gyne Cure

  • Trosyd Af

  • Trosyd J

Available Dosage Forms:


  • Cream

Chemical Class: Imidazole


Uses For Gyne Cure


Tioconazole belongs to the family of medicines called antifungals, which are used to treat infections caused by a fungus or yeast. They work by killing the fungus or yeast or preventing its growth.


Tioconazole cream is applied to the skin to treat :


  • ringworm of the body (tinea corporis);

  • ringworm of the foot (tinea pedis; athlete's foot);

  • ringworm of the groin (tinea cruris; jock itch);

  • tinea versicolor (sometimes called ``sun fungus''); and

  • yeast infection of the skin (cutaneous candidiasis).

Tioconazole is available in the following dosage forms:


  • Topical

  • Cream (Canada)

Before Using Gyne Cure


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Although there is no specific information comparing use of this medicine in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of tioconazole in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Proper Use of tioconazole

This section provides information on the proper use of a number of products that contain tioconazole. It may not be specific to Gyne Cure. Please read with care.


Apply enough tioconazole to cover the affected and surrounding skin areas, and rub in gently.


Keep this medicine away from the eyes.


Do not apply an occlusive dressing (airtight covering, such as kitchen plastic wrap) over this medicine unless you have been directed to do so by your doctor. To do so may cause irritation of the skin.


To help clear up your infection completely, it is very important that you keep using tioconazole for the full time of treatment , even if your symptoms begin to clear up after a few days. Since fungus infections may be very slow to clear up, you may have to continue using this medicine every day for several weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses .


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For topical cream dosage form:
    • For ringworm of the body or yeast infection of the skin:
      • Adults—Use two times a day for 2 to 4 weeks.

      • Children— Dose must be determined by your doctor.


    • For ringworm of the foot:
      • Adults—Use two times a day for up to 6 weeks.

      • Children— Dose must be determined by your doctor.


    • For ringworm of the groin:
      • Adults—Use two times a day for up to 2 weeks.

      • Children— Dose must be determined by your doctor.


    • For tinea versicolor (“sun fungus”):
      • Adults—Use two times a day for 1 to 4 weeks.

      • Children— Dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Gyne Cure


If your skin problem does not improve within:


  • 2 weeks for ringworm of the body or yeast infection of the skin, tinea versicolor, or ringworm of the groin;

  • 4 to 6 weeks for ringworm of the foot;

or if it becomes worse, check with your doctor.


To help clear up your infection completely and to help make sure it does not return, good health habits are also required. The following measures will help reduce chaffing and irritation and will also help keep the area cool and dry:


  • For patients using tioconazole for ringworm of the groin (tinea cruris; jock itch) :
    • Avoid wearing underwear that is tight-fitting or made from synthetic materials (for example, rayon or nylon). Instead, wear loose-fitting, cotton underwear.


  • For patients using tioconazole for ringworm of the foot (tinea pedis; athlete's foot) :
    • Carefully dry the feet, especially between the toes, after bathing.

    • Avoid wearing socks made from wool or synthetic materials (for example, rayon or nylon). Instead wear clean, cotton socks and change them daily or more often if the feet sweat a lot.

    • Wear sandals or other well-ventilated shoes.


  • For patients using tioconazole for ringworm of the body (tinea corporis) :
    • Carefully dry yourself after bathing.

    • Avoid too much heat and humidity if possible.

    • Wear well-ventilated, loose-fitting clothing.


If you have any questions about these measures, check with your health care professional.


Gyne Cure Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor as soon as possible if any of the following side effects occur:


Less common
  • Burning

  • itching

  • redness

  • skin rash

  • swelling

  • or other signs of skin irritation not present before use of this medicine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Gyne Cure Topical side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Gyne Cure Topical resources


  • Gyne Cure Topical Side Effects (in more detail)
  • Gyne Cure Topical Use in Pregnancy & Breastfeeding
  • Gyne Cure Topical Support Group
  • 7 Reviews for Gyne Cure Topical - Add your own review/rating


Compare Gyne Cure Topical with other medications


  • Vaginal Yeast Infection

Monday, 3 September 2012

Factor VII Deficiency Medications


Drugs associated with Factor VII Deficiency

The following drugs and medications are in some way related to, or used in the treatment of Factor VII Deficiency. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Factor VII Deficiency





Drug List:

sumatriptan



soo-ma-TRIP-tan


Commonly used brand name(s)

In the U.S.


  • Imitrex

Available Dosage Forms:


  • Tablet

Therapeutic Class: Antimigraine


Pharmacologic Class: Serotonin Receptor Agonist, 5-HT1


Uses For sumatriptan


Sumatriptan is used to treat acute migraine attacks in adults. It does not prevent migraine attacks nor treat certain types of migraine headaches (e.g., hemiplegic or basilar type).


Many people find that their headaches go away completely after they take sumatriptan. Other people find that their headaches are much less painful, and that they are able to go back to their normal activities even though their headaches are not completely gone. Sumatriptan often relieves other symptoms that occur together with a migraine headache, such as nausea, vomiting, sensitivity to light, and sensitivity to sound.


Sumatriptan is not an ordinary pain reliever. It will not relieve any kind of pain other than migraine headaches. sumatriptan is usually used for people whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers.


Sumatriptan has caused serious side effects in some people, especially people who have heart or blood vessel disease. Be sure that you discuss with your doctor the risks of using sumatriptan as well as the good that it can do.


sumatriptan is available only with your doctor's prescription.


Before Using sumatriptan


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sumatriptan, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to sumatriptan or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of sumatriptan in the pediatric population. Safety and efficacy have not been established.


Geriatric


Use of sumatriptan is not recommended in elderly patients with kidney problems, heart or blood vessel disease, or high blood pressure, and should not be used by elderly patients with liver problems.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking sumatriptan, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using sumatriptan with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Almotriptan

  • Dihydroergotamine

  • Eletriptan

  • Ergoloid Mesylates

  • Ergonovine

  • Ergotamine

  • Frovatriptan

  • Isocarboxazid

  • Linezolid

  • Methylergonovine

  • Methysergide

  • Naratriptan

  • Phenelzine

  • Procarbazine

  • Rizatriptan

  • Tranylcypromine

  • Zolmitriptan

Using sumatriptan with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Citalopram

  • Desvenlafaxine

  • Dexfenfluramine

  • Duloxetine

  • Escitalopram

  • Fluoxetine

  • Fluvoxamine

  • Milnacipran

  • Paroxetine

  • Reboxetine

  • Sertraline

  • Sibutramine

  • St John's Wort

  • Tapentadol

  • Venlafaxine

  • Vilazodone

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of sumatriptan. Make sure you tell your doctor if you have any other medical problems, especially:


  • Bleeding problems or

  • Blurred vision or

  • CNS disorders or

  • Kidney disease or

  • Liver disease or

  • Seizures or epilepsy, history of or

  • Stomach or intestinal bleeding—Use with caution. May make these conditions worse.

  • Cerebrovascular disease (e.g., stroke, transient ischemic attack), or history of or

  • Heart attack, history of or

  • Heart disease (e.g., angina) or

  • Hemiplegic or basilar types of migraine or

  • Hypertension (high blood pressure), uncontrolled or

  • Ischemic bowel disease or

  • Liver disease, severe—Should not be used in patients with these conditions.

  • Coronary artery disease, history of or

  • Diabetes or

  • Hypercholesterolemia (high cholesterol in the blood) or

  • Hypertension (high blood pressure), controlled or

  • Obesity or

  • Raynaud's syndrome—Use with caution. The chance of side effects may be increased. Heart or blood vessel disease sometimes do not cause any symptoms, so some people do not know that they have these problems. Before deciding whether you should use sumatriptan, your doctor may need to do some tests to make sure that you do not have any of these conditions.

Proper Use of sumatriptan


Do not use sumatriptan for a headache that is different from your usual migraines. Instead, check with your doctor.


To relieve your migraine as soon as possible, use sumatriptan as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using sumatriptan. Using sumatriptan during the aura probably will not prevent the headache from occurring. However, even if you do not use sumatriptan until your migraine has been present for several hours, the medicine will still work.


Lying down in a quiet, dark room for a while after you use sumatriptan may help relieve your migraine.


If you feel much better after a dose of sumatriptan, but your headache comes back or gets worse after a while, wait at least 2 hours before taking another dose. However, use sumatriptan only as directed by your doctor. Do not use more of it, and do not use it more often, than directed. Using too much sumatriptan may increase the chance of side effects. Do not take more than 200 mg in 24 hours.


You may take the tablet with or without food. Swallow the tablet whole with water or other liquids. Do not break, crush, or chew it.


sumatriptan comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.


Dosing


The dose of sumatriptan will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of sumatriptan. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (tablets):
    • For migraine headaches:
      • Adults—25, 50, or 100 milligrams (mg) as a single dose. If you get some relief, or if the migraine comes back after being relieved, another dose may be taken 2 hours after the last dose. Do not take more than 200 mg in any 24-hour period.

      • Children—Use and dose must be determined by your doctor.



Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using sumatriptan


Check with your doctor if you have used sumatriptan and have not had good relief. Also, check with your doctor if your migraine headaches are worse, or if they are occurring more often, than before you started using sumatriptan.


Make sure your doctor knows if you are pregnant. Your doctor may want you to join a pregnancy registry for patients taking sumatriptan.


sumatriptan may increase your risk of having a heart attack or stroke. This is more likely to occur if you already have a heart disease, if you smoke, if you are over 40, or if you have gone through menopause. People who use sumatriptan for a long time might also have a higher risk.


You should not take sumatriptan if you have used an MAO inhibitor (MAOI) such as isocarboxacid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within the past two weeks. Do not use sumatriptan if you have taken other migraine medicines (e.g., almotriptan, frovatriptan, naratriptan, rizatriptan, zolmitriptan, Axert™, Frova®, Amerge®, Maxalt®, or Zomig®) or an ergotamine medicine (e.g., methysergide, D.H.E. 45®, or Migranal®) within the past 24 hours.


Make sure your doctor knows about all the other medicines you are using. Sumatriptan may cause a serious condition called serotonin syndrome when taken with some medicines. This especially includes medicines used to treat depression, such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, olanzapine, paroxetine, sertraline, venlafaxine, Celexa®, Cymbalta®, Effexor®, Lexapro®, Luvox®, Paxil®, Prozac®, Sarafem®, Symbyax®, or Zoloft®. Check with your doctor first before taking any other medicines.


sumatriptan may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.


Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).


Check with your doctor right away if you have chest discomfort, jaw or neck tightness after using sumatriptan. Also, tell your doctor if you have sudden or severe abdominal or stomach pain after taking sumatriptan.


Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.


sumatriptan may cause some people to become dizzy, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert while you are using sumatriptan.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


sumatriptan Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Less common
  • Abdominal or stomach pain

  • anxiety

  • blurred vision

  • changes in patterns and rhythms of speech

  • chest pain or tightness

  • chills

  • cold sweats

  • coma

  • confusion

  • constipation

  • cool, pale skin

  • cough

  • decrease in the amount of urine

  • depressed mood

  • difficult or labored breathing

  • dizziness

  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

  • dry mouth

  • dry skin and hair

  • extreme thirst

  • fainting

  • fast, slow, irregular, pounding, or racing heartbeat or pulse

  • feeling cold

  • fever

  • flushed, dry skin fruit-like breath odor

  • hair loss

  • headache

  • hoarseness or husky voice

  • increased hunger

  • increased thirst

  • increased urination

  • muscle cramps and stiffness

  • nausea

  • neck, throat, or jaw pain

  • nervousness

  • nightmares

  • noisy, rattling breathing

  • paleness of the skin

  • pounding in the ears

  • seizures

  • shakiness

  • shivering

  • shortness of breath

  • slurred speech

  • sweating

  • swelling of the fingers, hands, feet, or lower legs

  • tightness in the chest

  • trouble with speaking

  • troubled breathing

  • troubled breathing at rest

  • unexplained weight loss

  • unusual tiredness or weakness

  • uterine bleeding between menstrual periods

  • vomiting

  • weight gain

  • wheezing

Rare
  • Arm, back, or jaw pain

  • blindness

  • blood in the eye

  • blood in the urine

  • bloody, black, or tarry stools

  • burning, dry, or itching eyes

  • chest pain or discomfort

  • chest tightness or heaviness

  • collection of blood under the skin

  • convulsions

  • cough producing mucus

  • deep, dark purple bruise

  • discharge, excessive tearing

  • eye redness, irritation, or pain

  • feeling of warmth or heat

  • flushing or redness of the skin, especially on the face and neck

  • inability to move the eyes

  • increased blinking or spasms of the eyelid

  • increased frequency of urination

  • increased need to urinate

  • itching, pain, redness, or swelling

  • lightheadedness, dizziness, or fainting

  • nerve pain

  • pain or burning during urination

  • passing urine more often

  • redness in the whites of eyes

  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

  • severe numbness, especially on one side of the face or body

  • severe or continuing stomach pain

  • sticking out of the tongue

  • swelling of the eye

  • swollen, painful, or tender lymph glands in the neck, armpit, or groin

  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

  • trouble with breathing, speaking, or swallowing

  • troubled breathing with exertion

  • twitching

  • uncontrolled twisting movements of the neck, trunk, arms, or legs

  • unusual bleeding or bruising

  • unusual facial expressions

  • vomiting of blood or material that looks like coffee grounds

  • weakness of the arms and legs

Incidence not known
  • Agitation

  • back, leg, or stomach pains

  • bleeding gums

  • bluish color of the fingernails, lips, skin, palms, or nail beds

  • changes in skin color

  • changes in vision

  • coma

  • decreased urine output

  • diarrhea

  • double vision

  • flushing or redness of the skin

  • general body swelling

  • headache, sudden, severe, and continuing

  • high fever

  • hives

  • hostility

  • inability to speak

  • irritability

  • itching

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • lethargy

  • loss of ability to use or understand speech or language

  • loss of appetite

  • loss of vision

  • migraine headache

  • muscle twitching

  • noisy breathing

  • nosebleeds

  • overactive reflexes

  • pain, tenderness, or swelling of the foot or leg

  • pinpoint red spots on the skin

  • poor coordination

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • rapid weight gain

  • rectal bleeding

  • redness, soreness, or itching skin

  • restlessness

  • seizures

  • severe or sudden headache

  • skin rash

  • sore throat

  • sores, ulcers, or white spots on the lips or in the mouth

  • sores, welting, or blisters

  • stupor

  • swelling of the face, ankles, hands, feet, or lower legs

  • swollen glands

  • talking or acting with excitement you cannot control

  • temporary blindness

  • trembling or shaking

  • unexplained bleeding or bruising

  • unusually warm skin

  • weakness in the arm or leg on one side of the body, sudden and severe

  • weight loss

  • yellowing of the eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Less common
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

  • change in color vision

  • change in hearing

  • continuing ringing or buzzing or other unexplained noise in the ears

  • difficulty seeing at night

  • difficulty with concentrating

  • difficulty with moving

  • disturbance of smell

  • drowsiness

  • ear drainage

  • earache

  • false or unusual sense of well-being

  • feeling of constant movement of self or surroundings

  • flushing or redness of the skin

  • general feeling of discomfort or illness

  • hearing loss

  • heartburn

  • heavy bleeding

  • increased sensitivity of the eyes to sunlight

  • itching ears

  • itching skin

  • joint pain

  • lack of coordination

  • loss of hearing

  • muscle aching or cramping

  • muscle stiffness or tightness

  • pain or tenderness around the eyes and cheekbones

  • sensation of spinning

  • sensitivity to heat

  • sleepiness

  • stuffy or runny nose

  • swollen joints

  • tearing of the eyes

  • tenderness of the skin and breasts

  • thirst

  • trouble with sleeping

  • unexpected or excess milk flow from breasts

  • unexplained runny nose or sneezing

  • unusually warm skin

  • weight gain or loss

Rare
  • Abnormal growth filled with fluid or semisolid material

  • acid or sour stomach

  • aggressiveness

  • agitation

  • anxiety

  • bad unusual or unpleasant (after) taste

  • belching

  • bigger, dilated, or enlarged pupils (black part of the eye)

  • blurred or loss of vision

  • bruise

  • change in personality

  • change in taste

  • changes in speech

  • clear or bloody discharge from the nipple

  • decreased appetite

  • dimpling of breast skin

  • disturbed color perception

  • double vision

  • dry or scaly skin

  • dry, flaky, scaling skin on the scalp, eyebrows, near the ears, and around the nose

  • feeling halos around lights

  • fluid or liquid from the nipple

  • full or bloated

  • heartburn

  • hiccups

  • hunger

  • increased alertness

  • increased sensitivity of the eyes to light

  • increased sensitivity to pain

  • increased sensitivity to touch

  • increased watering of the mouth

  • indigestion

  • inverted nipple

  • lack of feeling or emotion

  • loss of appetite

  • lump in the breast or under the arm

  • mouth or tooth pain

  • night blindness

  • numbness, pain, tingling, or weakness

  • overbright appearance of lights

  • persistent crusting or scaling of the nipple

  • pressure in the stomach

  • red, sore eyes

  • redness or swelling of the breast

  • seeing, hearing, or feeling things that are not there

  • skin rash, encrusted, scaly and oozing

  • small lumps under the skin

  • sore on the skin of the breast that does not heal

  • stomach discomfort, upset, or pain

  • swelling of the abdominal or stomach area

  • swelling of the breasts

  • swelling of the salivary glands

  • tightness of the skin

  • tingling in the hands and feet

  • tunnel vision

  • uncaring

  • weakness

  • wrinkled skin

Incidence not known
  • Deafness

  • panic

  • severe sunburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: sumatriptan side effects (in more detail)



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